Intelligent prosthetic socket system with active user feedback interface and real time prosthesis diagnostics

ABSTRACT

An apparatus is provided for use with a prosthetic system. The apparatus includes a controller and a wireless smart device. The controller operates to gather data and derive prosthetic information from a plurality of sensors, and transmits the prosthetic information over a wireless radio link, where the controller and the plurality of sensors are disposed within the interior of a prosthetic socket. The wireless smart device is coupled to the controller via the wireless radio link, and receives the prosthetic information, and provides visual and audio representations of the prosthetic information to a user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the following U.S. ProvisionalApplications, each of which is herein incorporated by reference for allintents and purposes.

SERIAL FILING NUMBER DATE TITLE 61/366,012 Jul. 20, 2010 INTERNAL SOCKETMOUNTED PROSTHETIC (AE.0103) VACUUM PUMP CONTROLLER AND DISPLAY61/388,322 Sep. 30, 2010 INTELLIGENT PROSTHETIC SOCKET SYSTEM (AE.0104)WITH ACTIVE USER FEEDBACK INTERFACE AND REAL TIME PROSTHESIS DIAGNOSTICS

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates in general to the field of biomechatronics, andmore particularly to a wireless intelligent prosthetic system havingreal time diagnostics and active user feedback.

2. Description of the Related Art

Prosthetics and prosthetic limbs have been used to replace human bodysince at least 1,000 B.C. Egyptian and Roman history is replete withrecitations of wooden toes, iron hands and arms, wooden legs, feet andthe like. However, it was not until the Renaissance that prostheticsbegan to provide for function (e.g., moving hands and feet) in additionto appearance. During this period the first prosthetic leg was developedhaving a suction socket that maintained a more effective and durableconnection between a patient's residual limb and the leg.

Since that time, and particularly during the past 75 years, developmentsin the field of prosthetic devices have flourished in this country,particularly with the help of funding from the National Academy ofSciences, the Armed Services, the American Orthotics and ProstheticAssociation, and other philanthropic entities. Beyond this country, TheInternational Society for Prosthetics and Orthotics continues to fosterboth research and clinical practice worldwide.

In the 1980s, socket technology evolved from sockets made in the shapeof a square bucket with no specialized adaptation to the specific sizeand shape requirements of the patient's residual limb to a socket thatconformed to the patient's limb like a glove. With this advancement,patients were enabled to perform activities over and above simplywalking—they were able to run, to walk both up and down stairs, and tostep over substantially large objects. Today, amputees even compete insports activities. And the pull on developers continues in this field asa result of these ever increasing needs.

Many patients are able to maintain a sufficient attachment of their limbto their prosthesis merely as a result of the good fit between aconforming socket and the limb, that is, gravity and friction do a goodenough job of keeping the socket and prosthesis attached. However, thereis a class of patients for whom maintaining an effective bond betweenlimb and socket is a continual and ever evolving challenge. For some inthis category, loss of “fit” is a result of changes in the size andshape of their residual limb. For others, the weight of the prosthesisrelative to the residual limb precludes a good bond during activity. Andfor others, changes in their type of activity (e.g., running versuswalking) cause the coupling between socket and limb to degrade.

It is for this class above that vacuum assisted devices and sockets havebeen more recently fielded. With a vacuum assisted prosthetic, thepatient's limb is shielded with a protective cover such as a siliconeliner over the top of which is placed a porous fabric sleeve, and thelimb is inserted into a vacuum assisted socket. Through an air port inthe socket, a vacuum pump is attached that is used to create a vacuumbetween the limb and the socket to enable the socket to be moreeffectively coupled to the limb. There are numerous developments in thisfield to include one-time external pumps, pumps that are carried by thepatient, and pumps that are affixed to the exterior of the socket or tothe prosthesis itself. Some pumps are manually operated. Other pumps areelectronically activated either via a special activator (e.g. RF fob) orby control functions designed therein. Still other pumps provide arudimentary form of automation that maintains a predetermined negativeair pressure inside the socket cavity. Of these more advancespumps/controllers, some are able to gather limited data regarding wearwhich can be accessed through the use of special test equipmenttypically at a prosthetic specialist's facility. Most of the fit andwear data to date, however, is obtained through personal interview withthe patient.

The present inventors have noted numerous limitations resulting from thestate of the art including the requirement for special equipmentrequirements to both operate and access data captured by today'spumps/controllers. In addition, because these devices are either carriedor mounted external to a prosthetic socket, additional manufacturingrequirements are imposed on a socket (e.g., ports for connection of airhoses and electrical leads), and the pumps/controllers themselves aresubject to damage due to their exposure to contaminants andunanticipated accidents. Furthermore, the present inventors haveobserved that the amount of data that is currently gathered by thesedevices is woefully lacking. As a result, the patient's prostheticexperience is problematic.

Accordingly, what is needed is an intelligent prosthetic socket systemthat can relay real time information to patients, where the informationis derived from a series of sensors and data collection components.

Additionally, what is needed is a prosthetic socket system that includesan intelligent pump/controller that is disposed inside of a socket andthat comprises a plurality of sensors for purposes of continuallyadjusting a vacuum between a residual limb and the socket.

Also what is needed is a prosthetic socket system including anintelligent pump/controller disposed inside of a prosthetic socket thatgathers data related to fit and usage of an associated prosthesis.

Furthermore, what is needed is an intelligent pump/controller internalto a prosthetic socket that communicates information wirelessly to/froma commercially available “smart” device such as an IPHONE®, IPAD®, IPODTOUCH®, or DROID®, where information from the smart device can beprovided over the Internet for access by the user and authorized agentssuch as prosthetic fitters and medical personnel.

Moreover, what is needed is an intelligent pump/controller internal to aprosthetic socket that communicates information wirelessly to/from amultifunctional “smart” device that allows for a much broader andextensible set of controls and displays over that which has heretoforebeen provided.

SUMMARY OF THE INVENTION

The present invention, among other applications, is directed to solvingthe above-noted problems and addresses other problems, disadvantages,and limitations of the prior art. The present invention provides asuperior technique for intelligently and automatically operating aprosthetic system over periods of time, both short term and long term.In one embodiment, an apparatus is provided for use with a prostheticsystem. The apparatus includes a controller and a wireless smart device.The controller operates to gather data and derive prosthetic informationfrom a plurality of sensors, and transmits the prosthetic informationover a wireless radio link, where the controller and the plurality ofsensors are disposed within the interior of a prosthetic socket. Thewireless smart device is coupled to the controller via the wirelessradio link, and receives the prosthetic information, and provides visualand audio representations of the prosthetic information to a user.

One aspect of the present invention contemplates an apparatus for usewith a prosthetic system. The apparatus includes a housing and awireless smart device. The housing has a controller and a seal. Thecontroller operates to gather data and derive prosthetic informationfrom a plurality of sensors, and transmits the prosthetic informationover a wireless radio link, where the controller and the plurality ofsensors are disposed within the interior of a prosthetic socket. Theseal seals the interior of the prosthetic socket from an ambientenvironment. The wireless smart device is coupled to the controller viathe wireless radio link, and receives the prosthetic information, andprovides visual and audio representations of the prosthetic informationto a user.

Another aspect of the present invention comprehends an apparatus for usewith a prosthetic system. The apparatus includes a prosthetic socket, ahousing, and a wireless smart device. The prosthetic socket provides aconforming receptacle for a residual limb of a user. The housing isdisposed at the distal end of the prosthetic socket. The housingincludes a controller and a seal. The controller gathers data andderives prosthetic information from a plurality of sensors, andtransmits the prosthetic information over a wireless radio link, wherethe controller and the plurality of sensors are disposed within theinterior of the housing. The seal seals the interior of the prostheticsocket from an ambient environment. The wireless smart device is coupledto the controller via the wireless radio link, and receives theprosthetic information, and provides visual and audio representations ofthe prosthetic information to the user.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features, and advantages of the presentinvention will become better understood with regard to the followingdescription, and accompanying drawings where:

FIG. 1 is a diagram illustrating a present day approach to attaching andsecuring a prosthetic device to a residual patient limb;

FIG. 2 is a diagram depicting a side view of an intelligent prostheticsystem according to the present invention;

FIG. 3 is a diagram featuring a cross-sectional view of the intelligentprosthetic system of FIG. 2 taken from line A-A to line B-B;

FIG. 4A is a detailed side view of an intelligent puck 400 according tothe present invention, as may be employed in the prosthetic system ofFIGS. 2 and 3;

FIG. 4B is a diagram illustrating a top cross-sectional view of the puckof FIG. 4A taken at line C-C;

FIG. 4C is a diagram detailing a bottom view of the puck of FIG. 4A;

FIG. 4D is a diagram showing a top view of the puck of FIG. 4A; and

FIG. 5 is a block diagram of a puck controller according to the presentinvention.

DETAILED DESCRIPTION

The following description is presented to enable one of ordinary skillin the art to make and use the present invention as provided within thecontext of a particular application and its requirements. Variousmodifications to the preferred embodiment will, however, be apparent toone skilled in the art, and the general principles defined herein may beapplied to other embodiments. Therefore, the present invention is notintended to be limited to the particular embodiments shown and describedherein, but is to be accorded the widest scope consistent with theprinciples and novel features herein disclosed.

In view of the above background discussion on present day prostheticdevices and associated techniques employed within the field to reliablyand effectively provide for adequate sealing and patient comfort, adiscussion of present day approaches for maintaining a seal between aprosthetic device (e.g., a prosthetic leg) and a patient's residual limbwill be presented with reference to FIG. 1. Following this, a discussionof the present invention will be presented with reference to FIGS. 2-5.The present invention overcomes the numerous limitations anddisadvantages of present day prosthetic devices by providing fullyenclosed wireless apparatus that enables real-time analysis and controlof patient and prosthetic operating parameters via a wireless deviceinterface.

Turning to FIG. 1, a diagram is presented illustrating a present dayapproach 100 for attaching and securing a prosthetic device 111 to aresidual limb 113 of a patient. As one skilled in the art willappreciate, prosthetic devices 100 are myriad in the art and arepredominately comprised of artificial limbs such as legs and arms, butmay also include subsets of these appendages to include feet and hands.In order to teach limitations of the art along with disclosure of thepresent invention, the example of a combination prosthetic leg and footwill be employed, however it is noted that the scope of the presentinvention is not to be restricted to this example as the apparatus andprinciples of operation extend to all such prosthetic devices. Inaddition, henceforth a patient having a residual limb to which aprosthetic device is attached will be referred to as a “user” and theentire system of apparatus comprising the prosthetic device (i.e., limb,structural components, socket, housing, covers, etc.) will be referredto as a “prosthetic system” 100.

Accordingly, the system 100 includes an artificial foot 111 (includingvertical structural components) fabricated from and by any of a numberof well known materials and processes. A socket 112 is coupled to thefoot 111 and a user's residual limb 113 is inserted into the socket 112.In many cases, gravity and friction alone are all that are needed toadequately secure the limb 113 to the system 100. However, as oneskilled in the art will appreciate, there are cases where the abovecoupling methods are insufficient, such as when a prosthesis 100 weighsmuch more than the residual limb, or when a prosthetic leg 100 isemployed under more stringent operating conditions (e.g., a racingprosthesis). In these cases it is customary to provide a vacuum seal toaffect a seal such that the prosthetic system 100 stays attached to theresidual limb 113. FIG. 1 shows one mechanism where vacuum techniquesare employed to maintain a seal between the residual limb 113 and theprosthesis 100.

In a vacuum assisted prosthesis 100, typically the residual limb 113 iscovered with a silicone sleeve (not shown) to protect the limb 113 fromeffects of the vacuum. While it is advantageous that a lower airpressure around the limb 113 that that of the ambient atmosphere has theadvantage of drawing blood and fluids into the limb 113, one skilledwill also appreciate that too much negative pressure will cause damageto the limb 113.

The sleeve is then covered with a sock (not shown) made of porous fabricsuch as cotton, polyester blend, or the like to allow for air movement.Thus, the covered limb 113 is inserted into a socket 112, to which thefoot 111 is mechanically attached. The attachment techniques vary, butgenerally the socket 112 is secured to the foot 111 by bolts that arethreaded into inserts (not shown) at the top of the foot structure 111.The socket 112 is typically thermoplastic or laminated shell that isformed to comport with the shape of the residual limb 113. The socket112 is then covered by a rubber sleeve 114 that at the top end securesthe sleeve 114 to the covered limb 113 and at the bottom secures thesleeve 114 to the socket 112. A vacuum is created within to secure thesleeve 114 to the covered limb 113 and to secure the sleeve 114 to thesocket 112.

There are many known methods of drawing air from the inside of thesocket 112 to the outside of the socket 112 to create the level ofnegative internal pressure necessary to secure the socket 112 to thelimb 113, but the present inventors have noted that all of these methodsinvolve a pump (not shown) that is external to the socket 112. This pumpmay be attached to the socket 112 or it may be freestanding. It may befully mechanical and operated by the change in angle between theartificial foot 111 and the piston, or it may be an electrical pumpmounted on the system 100. Other variations include an electrical pumpmounted inside the socket 112 with an electronic controller mounted onthe artificial leg/foot 111. Regardless of the configuration, thepresent inventors have noted that present day mechanisms as describedabove all require user intervention to adjust the vacuum setting basedon anticipated activity. It is noted that in the case of a mechanicalpump, many users are heavy enough to actuate the pumping mechanism andthese types of devices provide not way to regulate internal airpressure.

In many of the above configurations, access to the interior of thesocket 112 is generally gained through a port (not shown) on the socketitself. Thus, the user accesses the pump at a fixed location, or carriesthe pump, or the pump is secured to the socket 112 or to the foot 112,and an air hose and electrical leads (if required) couple the pump tothe socket 112. The present inventors have observed that having a pumpat a fixed location is disadvantageous because vacuum leaks most oftenoccur during use, which may not be at the fixed location. In addition,an external pump increases the risk of damage to the pump during use andrender the prosthesis more visually obvious.

Known pumping apparatus also includes special purpose electro-mechanicaldevices that most often include external sensors and wires-piercing thewall of the socket 112 and creating a point for potential vacuumleak—coupling a pump thereto, and these devices can only be accessed viaspecial purpose equipment that most often is not available to the user.That is, the user must travel to a designated location in order tocommunicate device usage and wear information to the special purposeequipment. Accordingly, information analysis is not performed in realtime. More often, most of the information needed to adjust theprosthetic device 111 and socket 112 for fit and performance is obtainedthrough a personal interview with the patient. In the case of a morecapable pumping device, the information is obtained by coupling thespecial purpose equipment to the device at a manufacturerrepresentative's site either via wired or wireless connection. Thepresent inventors have noted that requiring an access port on the wallof the socket 112 increases the cost of manufacturing, and overall costto the user since sockets are frequently replaced resulting from wearand fit issues. In addition, present day devices provide very limitedinformation on the operation of the vacuum setting. Consequently, aprosthetic fitter must estimate the level of vacuum setting that may berequired for each user. In terms of control, some electrical pumps havecontrol switches mounted thereon or are actuated by a custom wireless RFfob.

In addition, any real-time information that is obtained by present daypumping devices is communicated to the user via very rudimentary anduser-unfriendly mechanisms, such as coded audio or visual signals. Somedevices include prosthetic controllers that when coupled to the specialpurpose equipment are capable of affecting a small range of controlsettings (e.g., vacuum level). The user may be able to turn the pump onand off or it may work automatically to provide a predetermined level ofvacuum.

The present inventors have observed that there are available systemsthat gather data and that perform rudimentary prosthetic user alerts asdescribed above. However, all of these systems have pumping devices thatare not part of the prosthetic socket 112. The majority of the designsinclude numerous wires and sensors that have to be ported inside theprosthetic socket 112 with a monitoring device that is external to thesocket 112. In addition, these prosthetic systems 100 are not portable(i.e., they are not reusable when a socket 112 is replaced), and theyare difficult to fabricate. No existing device has a real time dialogwith the user other than simple audio and visual alerts. The presentinventors have also observed that there is no prosthetic system 100today which is portable, which operates in real time, and which iscapable of communicating to the user in an ongoing dialog instructionsfor operation or indications of misfit or malfunction. Consequently,users are constrained to accept the type of fit and comfort that thesesystems 100 are capable of providing.

For the above reasons, and others, the present inventors have noted aneed in the art for an intelligent prosthetic system that gathers andanalyzes data in real time, and that affects an ongoing two-way dialogwith a user for purposes of awareness and control. The present inventorshave also determined a need for the intelligent prosthetic system to befabricated such that the pump itself and all sensors are internal to asocket 112 in order to preclude potential vacuum leaks. And there is aneed for such an intelligent pumping apparatus having sensing andcontrol components therein to communicate wirelessly to the user viacommercially available and cost effective mechanisms, and that do notrequire additional control devices (e.g. a special fob) beyond what isnormally carried by the user. The present inventors have further notedthat it is desirable for such a prosthetic system to include mechanismsfor reuse when the user swaps out a socket 112. The present inventorshave moreover observed that it is desirable to provide for easy upgradeof functionality of the prosthetic system 100 without a requirement todisassemble major components.

The present invention overcomes the limitations alluded to above andfurthermore achieves each of the preceding objectives through acombination of smart-device wireless technologies and a programmedintelligent internal pump and control apparatus. In one embodiment, thepresent invention comprises a microprocessor controlled socket coupledto a smart device (e.g., smart phone, IPHONE®, IPAD®, ANDROID® phone,WINDOWS®-based phone, personal digital assistant (PDA), or like devices)for user feedback and prosthetic socket adjustments. Hereinafter, thesetypes of devices will be referred to as a smart device. It is throughthe use of an every day smart device that all of these control optionsand intelligent socket features become possible and useable. Previousdevelopments in the art have not incorporated a smart device, thus theonly time the data could be adjusted or gathered was to connect the aprosthetic system to a computer and download information. The presentinvention provides the advantage of using a single component withmultiple sensors and an on board central processing unit (CPU),microprocessor, or microcontroller housed inside the prosthesis, andwirelessly coupled to display screens and functions available in thesmart device. In addition, the use of a smart device allows the data tobe transmitted in real time via the Internet to a prosthetic fitter whois monitoring fit and use.

The present invention furthermore provides for a real-time prostheticuser feedback system coupled to a computer controlled system thatderives information from a multitude of sensors and other elements torelay information to the user. A control module according to the presentinvention reports information to the user via the smart device throughclear concise written messages and warnings. User information willinclude internal socket conditions including, but not limited totemperature, vacuum level, moisture, movement, pressure, and externalsocket conditions including, but not limited to, angle indications,altitude, Global Positioning System (GPS) parameters, accelerometerparameters, force information, gyroscopic information, camerainformation, memory card information, and timer/clock values. Thecontroller according to the present invention monitors and adjustssocket conditions through bladder systems, temperature control systems,suspension control mechanisms, and etc.

The present invention moreover provides for understandable communicationwith the user. The communication provides for written or verbalinstructions to user, in contrast to present day beep and vibratoryalarms, by real-time data and exact instructions for what to do with theprosthesis. For example, the device according to the present inventionwill inform prosthetic users when to add a prosthetic sock (a way oftightening the prosthetic system), when to remove a sock because thereis not enough distal contact, when to change a fabric liner becausethere is too much moisture, when to service the prosthesis or parts ofthe prosthesis. The device according to the present invention willadvise the user to adjust pressure because of a change in altitude, itwill provide pedometer information (e.g., steps walked, feet climbed,cadence, speed). The device will record and provide the time theprosthesis has been worn, and display and guide the user through awearing schedule. The present invention will advise the user if abnormalmovement is detected (e.g., pistoning), and it will record data onprosthetic wear, suspension effectiveness, and compliance to the userschedule. The device will also be able to store and display all of thepertinent information about the prosthesis (e.g., foot, size, category,patient weight, date fit, knee unit, knee settings, socket design, linertype, suspension type, etc.) An alternative embodiment additionallyprovides for a clinical data section to help with medicaljustifications, and to provide pertinent clinical data for prosthetiststo analyze data and resolve fit issues.

In a further embodiment, the data system is connected to other systemsthat control bladder systems, vacuum systems, fluid control systems,temperature control systems, emergency systems, suspension systems,mechanical and electrical alignment/gait control systems automaticallybased on the information collected and derived from the on board socketcontrol and feed back system.

Advantageously, the system according to the present invention ismodular—a removable and reusable unit—that is, in one embodimentdisposed inside a prosthetic socket with sensors and diagnostic tools torelay information to prosthetic users. Many prosthetic users haveinsensate residual limbs (i.e., no feeling) and they are unable todetect when to check their limb for pressure. Some users cannot rememberhow long to wear the limb. When to add and remove socks is also a bigproblem for many users. Often times suspension is no longer adequate andusers cannot detect micro movement in a prosthesis. Every prosthesisrequires service; many patients forget to have regular service checksperformed. The present invention overcomes these limitations byproviding a mechanism that can determine if any of the aforementionedcircumstances have transpired and will communicate this with the userwirelessly via a conventional smart device. The present invention willnow be discussed with reference to FIGS. 2-5.

Turning to FIG. 2, a diagram 200 is presenting depicting a side view ofan intelligent prosthetic system according to the present invention. Thesystem includes a prosthetic socket 203 having extra volume at thedistal end into which a smart device 204 is placed. Hereinafter, thesmart device 204 may be referred to as a “puck” 204 due to itsresemblance to a hockey puck. The puck 204, among other features,includes, in one embodiment, a CPU, memory, power supply, a wirelessinterface, and a plurality of sensors. In one embodiment, the powersupply comprises a rechargeable battery that is accessed for chargingvia a port on the top of the puck. Another embodiment contemplates aninductively charged battery that is recharged in proximity to aninductive recharging pad. One embodiment considers an applicationprogram disposed within the memory that provides for one or more of thefunctional features disclosed above. Alternative embodiments contemplateone or more of the following sensors coupled to the CPU and disposedwithin the puck 204: accelerometer, GPS sensor, barometric pressuresensor, and temperature sensor. Other embodiments envisage one or moreof the sensors disposed external to the puck 204, situated within thesocket 203, and coupled to the CPU through sealed access points in thecover of the puck 204.

The puck 204 also includes a vacuum pump that is controlled by the CPU.The vacuum pump has an intake port that is coupled to a low pressureport on the top of the puck 204 and an exhaust port that is coupled toan exhaust port on the bottom of the puck 204. The application programexecutes on the CPU to affect control of the pump in accordance withprogrammed parameters and data that is read by the sensors. Oneembodiment of the puck 204 includes an airtight and watertight seal thatseals the puck 204 to the socket 203 so that an appropriate vacuum canbe established on the intake side of the puck 204 and air can bedischarge via the exhaust side of the puck, typically into a verticalstructure 202 that forming a hollow leg portion of a combination leg andfoot prosthesis. In one embodiment a prosthetic foot 201 is coupled tothe vertical structure 202. The socket 203, vertical structure 202, andfoot 201 are all fabricated by known means, as alluded to above. Asnoted above, other embodiments of the present invention include such asystem configured as a prosthetic arm/hand combination, a prostheticfoot, and a prosthetic hand. A residual limb 206 is inserted into thesocket 203 as described above and the system is configured to maintain aseal between the residual limb 206 and the socket 203 such that thesystem stays coupled to the limb 206.

In one embodiment, programming of the puck 204 provides for defaultlevels of vacuum inside the socket and the air pressure within thesocket is automatically maintained in accordance with data read throughthe sensors. The puck 204 communicates wirelessly with a smart device206 for purposes of providing information and alerts to a user, as hasbeen described above. In another embodiment, the user may additionallyemploy touch controls on the smart device 206 to override thepredetermined air pressure levels. That is, the user can take control ofthe pump via the smart device 206. In addition, the user may indicatevia the smart device 206 that a different operating mode is to beemployed, such as sprinting versus walking, which requires a differentpressure level to maintain a good seal in the socket.

The puck 204 optionally includes a manual switch 205 to allow the userto operate the pump in the absence of the smart device 206 or in theevent that the smart device 206 fails. One embodiment of the switchcontemplates a sealed push-on/push-off (momentary contact) switch thatis sensed by the CPU. Another embodiment envisages a Hall effect switchdisposed internally in the puck 204, where the Hall Effect switch isactivated by a magnetic device (e.g., a wand) having a level of magneticflux that is adequate to actuate the switch when held in proximitythereto. The present inventors note that according to the presentinvention no vacuum inlet on the socket 203 is required, in contrast tothat which has been provided heretofore.

Now referring to FIG. 3, a diagram 300 is presented featuring across-sectional view of the intelligent prosthetic system of FIG. 2taken from line A-A to line B-B. The diagram 300 shows a silicone liner301 that covers a residual limb. The liner 301 is covered with a porousfabric sleeve 302 which is inserted into a socket 303 according to thepresent invention. The socket 303 has a formed reservoir at its distalend in which a puck 304 according to the present invention is disposed.The puck has a primary seal 306 that contacts with the socket to form aseal separating a low pressure side of the system (i.e., the sideadjacent to the fabric sleeve 303) form a high pressure side of thesystem. The puck 304 includes an intake port 308 on the low pressureside and an exhaust port 310 on the high pressure side. The puck 304includes threaded receptacles where bolts are inserted through holes 307in the distal end of the socket 303. An exhaust hole 309 is alsoprovided in the socket 303 through which air is discharged from theexhaust port 310. As noted earlier, the puck 304 may include an overridecontrol switch 305.

In operation, a controller (not shown) within the puck 304 is programmedto execute one or more of the above noted functions and to communicatedwirelessly with a smart device to maintain an effective vacuum sealbetween the limb and the socket 303 under varied use conditions.

Turning now to FIG. 4A, a diagram is presented showing a detailed sideview of an intelligent puck 400 according to the present invention, asmay be employed in the prosthetic system of FIGS. 2 and 3. The puck 400comprises a cylindrical housing 410 having a top and a bottom. In oneembodiment the housing 410 is fabricated aluminum and the bottom hasfour threaded receptacles 405 for mounting bolts that pass through holesin the distal end of a socket according to the present invention, andwhich attach the socket to a vertical prosthesis structure. Otherembodiments contemplate a housing 410 fabricated from any material(e.g., plastic) strong enough for the application. The bottom of thehousing 410 also has an exhaust port 407 that is coupled to a highpressure side of a pump internal to the housing 410. The top of thehousing 410 has an inlet port 409 that is coupled to a low pressure sideof the pump. Around the top of the housing a primary seal 402 isdisposed that seals the puck 400 to the socket. An optional switch 406,as described above, may be present on the side of the housing. In oneembodiment, the puck housing 410 itself (i.e., no internal components)can be effectively employed as a modular negative pressure tank thatseal the distal aspect of a conforming socket.

In one embodiment, components as described above (e.g., power supply,CPU, memory, sensors) may be disposed on a printed circuit board 401having electrical and pneumatic leads that couple components on theboard 401 to the switch 406, a charging port 408, pressure ports 409,407, and any sensors (not shown) external to the housing 410.

FIG. 4B is a diagram illustrating a top cross-sectional view of the puck400 of FIG. 4A taken at line C-C. The diagram shows how a sealedmomentary switch 411 a having cap 412, an actuator 413, and internalcontacts 410 may optionally be configured on the housing 401. As notedabove, a Hall Effect switch may be mounted internal to the housing,precluding the need to modify the housing 410 or the socket for externalactuation.

FIG. 4C is a diagram detailing a bottom view of the puck of FIG. 4A. Ahigh pressure side port 407 is provided at center of the bottom withfour threaded holes 405 spaced around the port 407 to provide forattachment of the socket to vertical structure members of theprosthesis. The primary seal 402 surrounds the top of the puck 400. Asnoted above, air is discharged by the pump through the exhaust port 407and into the structure members.

FIG. 4D is a diagram showing a top view of the puck of FIG. 4A. Theprimary seal 402 surrounds the top of the puck 400 and a vacuum inletport 409 is disposed in the center of the top. In one embodiment, theinlet port 409 comprises a waterproof filter. Additionally, a chargeport 408 is disposed on the bottom of the puck to allow a chargingdevice to be coupled to the battery. One embodiment of the presentinvention contemplates a socket having a hole around the charge port 408to allow the puck 400 to plug in to a charging device.

FIG. 5 is a block diagram of a puck controller 500 according to thepresent invention. Elements of the controller 500 may be disposed on thecircuit board 401 of FIG. 4A. The controller 500 includes a power supply501 that provides power to the controller 500. In one embodiment thepower supply 501 comprises a rechargeable battery. The supply 501 iscoupled to the charge port 408. The controller 500 includes a CPU 502that is coupled to an override switch 514 as described above, and to amemory 515. In one embodiment, the memory 515 comprises flash read-onlymemory (ROM) and the CPU 502 includes random access memory (RAM).Another embodiment contemplates that the memory 515 comprises acombination of any well known ROM and RAM. An application programproviding for the functions disclosed herein is stored in the ROMportion of the memory 515. Sensors that may be coupled to the CPU 502include an accelerometer 503, a GPS receiver 504, a barometric pressuresensor 505, a temperature sensor 506, and any other type of sensor 512that may be employed to perform additional functions as programmed intothe application program. For example, sensor 512 may comprise a straingauge that is mounted on the top of the puck to detect excess limbpressure. Another embodiment contemplates sensor 512 comprising one ormore gyroscopes to provide gyroscopic information. Accordingly theapplication program will execute so that the user is informed on thesmart device that the limb is seated to low in the socket.

A wireless interface 507 is also coupled to the CPU. In one embodiment,the wireless interface 507 comprises a BLUETOOTH® transceiver. Anotherembodiment contemplates an IEEE 802.11 transceiver. The wirelessinterface 507 is employed by the CPU to communicate with a wirelesssmart device 508 via a wireless link 509. A device application program(not shown) resides within the smart device 508 to provide for smartdevice functions as described above.

A vacuum pump 513 as described above is also coupled to the CPU and iscontrolled by the CPU.

Optionally, the wireless device 508 is coupled to the Internet via anyof a number of well known wireless links 510, which provides connectionto a web data server 511 for purposes of device monitoring.

Operationally, the application program in the memory 515 and itscounterpart in the smart device 508 operate to control functions of thesmart prosthesis system as described above by reading and analyzing datafrom the sensors 503, 504, 505, 506, 512, and the switch 514.Accordingly, the CPU 502 actuates the vacuum pump 513 to maintain aneffective seal between the limb and the socket under conditions directedby the user through use of the smart device 508.

One advantage of the present invention is that a modular designembodiment of the puck having pump and all sensors located thereinenables a socket fabricator to easily move the puck from an older socketto a newer socket. Another benefit of the present invention is thatmultiple sensors are provided to allow for more precise automatic vacuumlevel adjustments that adapt to a user's change in activity level.

The present invention additionally provides a mechanism for displayingand controlling many more parameters regarding fit and function ofprosthetic members than which enables a prosthetic device manufacturerto provide a better and more comfortable fit for the user.

An additional benefit provided by the present invention is that the useris not required to carry extra pump control devices such as an RF fob.Complete control of the prosthetic system is achieved through a smartdevice which most user's now carry on their person.

Because of the design of the puck according to the present invention,all holes heretofore required in the socket for hoses or electricalleads have been eliminated.

Many prosthetic sockets have a distal attachment plate. Since oneembodiment of the present invention provides an aluminum puck housingthat mounts the socket to vertical structural members, a requirement toprovide the distal attachment plate is removed, thus reducing the costof a prosthetic socket. And because all controller and pumping hardwareis mounted internal to the socket, these elements are subject to impactdamage. There are no hoses and wires to be snagged and damaged. Theelements are protected from foreign object ingestion.

Mounting the pump inside of a socket reduces the noise level of thedevice when pumping, resulting in a more socially comfortableenvironment for the user and those nearby.

Because the present invention utilizes existing smart devices such as anIPHONE, IPAD, ANDROID phone, or the like, application software disposedtherein can be upgraded easily by the users under current processesprovided for by companies such as APPLE COMPUTER® and GOOGLE®. Inaddition, the application software/firmware within the puck controllercan be automatically updated remotely.

Because the present invention provides for connectivity to the Internet,data collected for a particular system can be easily accessed by otherentities such as medical and emergency personnel, insurance companies,and other prosthetic fitters.

Because of the virtually unlimited memory provided by connectivity to aweb data server, the present invention provides long term collection andanalysis of activity and wear parameters that enhance medical recordkeeping, training, and progress tracking,

Although the present invention and its objects, features, and advantageshave been described in detail, other embodiments are encompassed by theinvention as well. For example, although the present invention has beendiscussed predominately in terms of a puck having a vacuum pump, acontroller, and multiple sensors disposed therein, other embodiments arecontemplated to include adaptations of the modular puck housing toprovide for alternative prosthetic suspension mechanisms. In oneembodiment, the top portion of the housing is removed and replaced withapparatus such as, but not limited to, pin locks, lanyards, suction,expulsion valves, magnetic locks, or a negative pressure reservoir.

Those skilled in the art should appreciate that they can readily use thedisclosed conception and specific embodiments as a basis for designingor modifying other structures for carrying out the same purposes of thepresent invention, and that various changes, substitutions andalterations can be made herein without departing from the scope of theinvention as defined by the appended claims.

1-42. (canceled)
 43. An apparatus for use with a prosthetic system, theapparatus comprising: a controller configured to gather data and deriveprosthetic information from a plurality of sensors, and configured totransmit said prosthetic information using a wireless radio link,wherein said controller and said plurality of sensors are disposedwithin a housing that is contained within an interior cavity of aprosthetic socket, said prosthetic socket adapted to receive a residuallimb into said interior cavity, said residual limb having a cover, saidprosthetic socket comprising a reservoir within said interior cavityinside, said housing disposed with said interior cavity, and whereinsaid housing presents a first surface for contacting a second surface ofsaid covered residual limb when inserted into said interior cavity; apump, wherein the pump is coupled to said controller and wherein thepump is operable to maintain a prescribed negative air pressure withinsaid prosthetic socket, and wherein the pump is disposed within thehousing; and a mobile device coupled to said controller via saidwireless radio link.
 44. The apparatus of claim 43, wherein saidplurality of sensors comprises: an accelerometer for sensing relativemotion data corresponding to the prosthetic system, and for providingsaid relative motion data to said controller, wherein said controllerderives a portion of said prosthetic information based upon saidrelative motion data.
 45. The apparatus of claim 43, wherein saidwireless radio link comprises a BLUETOOTH radio link, and wherein saidmobile device comprises a mobile device.
 46. The apparatus as recited inclaim 45, wherein said mobile device executes an application programthat enables said mobile device to receive and transmit said prostheticinformation and to receive input from said user for transmission to saidcontroller.
 47. The apparatus of claim 46, wherein said mobile deviceprovides a visual or audio representation of said prosthetic informationto a user.
 48. The apparatus of claim 47, wherein said visual or audiorepresentation comprise an alert concerning excess pressure within saidprosthetic socket.
 49. The apparatus of claim 43, wherein said cover forsaid residual limb is a liner.
 50. The apparatus of claim 49, whereinsaid liner is a silicone liner contained within a sleeve.
 51. Anapparatus for use with a prosthetic system, the apparatus comprising: acontroller configured to gather data and derive prosthetic informationfrom a plurality of sensors, and configured to transmit said prostheticinformation over a wireless radio link, wherein said controller and saidplurality of sensors are disposed within a housing that is containedwithin an interior cavity of a prosthetic socket that is adapted toreceive a residual limb into said interior cavity, said residual limbhaving a cover, said prosthetic socket having a formed reservoir withinsaid interior cavity inside of which said housing is disposed, whereinsaid housing presents a first surface for contacting a second surface ofsaid covered residual limb when inserted into said interior cavity; apump coupled to said controller, wherein the pump is operable tomaintain a prescribed air pressure within said prosthetic socket, andwherein the pump is disposed within the housing.
 52. The apparatus ofclaim 51, wherein said prescribed air pressure is a negative airpressure.
 53. The apparatus of claim 51, further comprising a seal forsealing said housing to said interior receptacle.
 54. The apparatus ofclaim 51, wherein said plurality of sensors comprises: an accelerometerfor sensing relative motion data corresponding to the prosthetic system,and for providing said relative motion data to said controller, whereinsaid controller derives a portion of said prosthetic information basedupon said relative motion data.
 55. The apparatus of claim 51, whereinsaid cover for said residual limb is a liner.
 56. The apparatus of claim55, wherein said liner is a silicone liner contained within a sleeve.57. The apparatus of claim 51, further comprising a mobile deviceadapted to receive said prosthetic information.
 58. The apparatus ofclaim 57, wherein said mobile device provides a visual or audiorepresentation of said prosthetic information to a user.
 59. Theapparatus of claim 57, wherein said visual or audio representationcomprises an alert concerning excess pressure within said prostheticsocket.
 60. The apparatus of claim 51, wherein said wireless radio linkcomprises a BLUETOOTH radio link.
 61. The apparatus of claim 57, whereinsaid mobile device is configured to execute an application program thatenables said mobile device to receive and transmit said prostheticinformation.
 62. An apparatus for use with a prosthetic system, theapparatus comprising: a prosthetic socket for receiving a residual limbof a user, said residual limb having a cover; a housing contained withinsaid formed reservoir of said interior receptacle, wherein said housingpresents a first surface for contacting a second surface of said coveredresidual limb when inserted into said interior receptacle, said housingcomprising: a controller configured to gather data and derive prostheticinformation from a plurality of sensors, and that transmits saidprosthetic information over a wireless radio link, wherein saidcontroller and said plurality of sensors are disposed within saidhousing; a seal for sealing said interior receptacle from an ambientenvironment; a pump, wherein the pump is coupled to said controller andwherein the pump is operable to maintain a prescribed air pressurewithin said prosthetic socket; a mobile device, coupled to saidcontroller via said wireless radio link, for receiving said prostheticinformation.